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TBG Cementless Hip Stem, Ti-HA coating
EUDAMEDClass III (EU MDR)
Ref 130510006SRef 130520007SRef 130530008SRef 130490004SRef 130470002S
Identity
- Device Name
- TBG Cementless Hip Stem, Ti-HA coating EUDAMED
- Model / Reference
- 130510006S EUDAMED130520007S EUDAMED130530008S EUDAMED130490004S EUDAMED130470002S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06902139329424 EUDAMED06902139329431 EUDAMED06902139329448 EUDAMED06902139329400 EUDAMED06902139329387 EUDAMED
- Basic UDI-DI
- B-06902139329424 EUDAMEDB-06902139329431 EUDAMEDB-06902139329448 EUDAMEDB-06902139329400 EUDAMEDB-06902139329387 EUDAMED
- EMDN Code
- P090804010202 UNCEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, ANATOMICAL EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Croatia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
TBG Cementless Hip Stem, Ti-HA coating by Double Medical Technology Inc. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06902139329424 | Class III | Active |
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Manufacturer
- Manufacturer
- Double Medical Technology Inc.
- EUDAMED SRN
- CN-MF-000009048
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (5)
- EUDAMED 707db854-dd4c-4995-bdc3-16d0e0670483 61 fields · synced Aug 2, 2026
- EUDAMED 946f255a-3906-4103-8fc8-82aef4ca59fc 61 fields · synced May 18, 2026
- EUDAMED a3af2e5c-bba4-4236-9c3f-c2f606189f81 61 fields · synced May 18, 2026
- EUDAMED a1f473bb-cf3b-43ae-b3c3-5c00bb24e22d 61 fields · synced May 18, 2026
- EUDAMED 7aea2a23-3d60-473e-9d35-180643742edc 61 fields · synced May 19, 2026